Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00891995|
Recruitment Status : Terminated (Primary outcome evaluation determined lack of treatment group difference)
First Posted : May 1, 2009
Results First Posted : October 27, 2016
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Closed loop Device: Home glucose monitoring Device: Insulin pump Device: Continuous glucose monitor||Phase 2 Phase 3|
The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process.
Following completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management.
All subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Intensive Treatment
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
Device: Closed loop
Closed loop therapy for up to 4 to 6 daysDevice: Home glucose monitoring
Standard diabetes management using a home glucose meter.Device: Insulin pump
Insulin pump use for 2 yearsDevice: Continuous glucose monitor
Continuous glucose monitor use for 2 years
Active Comparator: Standard Treatment
home glucose monitoring (2 years)
Device: Home glucose monitoring
Standard diabetes management using a home glucose meter.
- C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment. [ Time Frame: At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal ]In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).
- Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]
- Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.
- HbA1c [ Time Frame: 1 year ]
- Adverse Events (Severe Hypoglycemia) [ Time Frame: 1 year ]
- CGM Mean Glucose [ Time Frame: 1 year ]
- CGM Measured Glucose Outcomes [ Time Frame: 1 year ]Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.
- Daily Insulin Dose [ Time Frame: 1 year ]
- BMI Percentile [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891995
|United States, California|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes|
|Aurora, Colorado, United States, 80010|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Roy W Beck, M.D., Ph.D.||Jaeb Center for Health Research|
|Principal Investigator:||Jay S. Skyler, M.D., M.A.C.P.||University of Miami|